Les v. Reilly
1992 WL 153883, 968 F. 2d 985 (1992)
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Rule of Law:
The Delaney Clause of the Federal Food, Drug, and Cosmetic Act establishes a zero-risk, absolute prohibition against food additives found to induce cancer, and does not permit a 'de minimis' risk exception.
Facts:
- Four pesticides—benomyl, mancozeb, phosmet, and trifluralin—were permitted for use on raw agricultural commodities.
- When the raw commodities were processed into foods like raisins or oils, the concentration of these pesticide residues increased above the levels permitted on the raw items.
- In 1988, the Environmental Protection Agency (EPA) determined that these four pesticides were substances that induce cancer in humans or animals.
- Despite finding the pesticides to be carcinogenic, the EPA continued to permit their use as additives in processed foods.
- The EPA justified its decision by creating a new policy, reasoning that the cancer risk posed by the pesticides was 'de minimis,' or negligibly small.
Procedural Posture:
- Petitioners filed an administrative petition with the Environmental Protection Agency (EPA) in May 1989, requesting the revocation of food additive regulations for four carcinogenic pesticides.
- The EPA issued a Notice of Response, refusing to revoke the regulations based on its 'de minimis' risk policy.
- Petitioners filed objections to the EPA's response.
- The EPA published its final order in February 1991, denying the petition to revoke the regulations.
- Petitioners sought review of the EPA's final order in the U.S. Court of Appeals for the Ninth Circuit.
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Issue:
Does the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits any food additive 'found to induce cancer,' permit the Environmental Protection Agency to allow the use of carcinogenic pesticides as food additives if the agency determines the cancer risk is de minimis?
Opinions:
Majority - Schroeder
No. The Delaney Clause does not permit a de minimis exception for carcinogenic food additives. The plain language of the statute is clear and mandatory, stating that no additive shall be deemed safe if it is found to induce cancer. The court's reasoning is based on the statute's unambiguous text, its legislative history, and its consistent historical interpretation. The legislative history reveals that Congress, concerned about scientific uncertainty regarding safe levels of carcinogens, intended to create a rigid, zero-tolerance standard to 'slam the door shut' on cancer-causing substances in food. Furthermore, the statutory scheme specifically subjects pesticides that concentrate in processed foods to this strict standard, distinguishing them from pesticides on raw foods. For over 30 years, the clause was interpreted as an absolute bar, and any policy change to allow for risk-based exceptions must come from Congress, not the agency or the courts.
Analysis:
This decision solidifies the Delaney Clause as a strict, bright-line rule rather than a flexible standard subject to agency risk assessment. It reinforces the principle of statutory textualism, holding that an agency cannot create exceptions to an unambiguous congressional mandate, even if the agency believes the mandate is scientifically outdated or leads to paradoxical outcomes. The ruling places the burden of modernizing food safety laws squarely on Congress, preventing regulatory bodies from unilaterally altering statutory schemes through reinterpretation. This has significant implications for food and drug regulation, forcing agencies to adhere to absolute prohibitions until the legislature explicitly provides for risk-based analysis.
